Systems and methods for moving and/or restraining tissue in the upper respiratory system

ABSTRACT

Systems and methods selectively stabilize tissue in the oral cavity. The systems and methods implant a first implant element in a bone region within an oral cavity and implant a second implant element in a tongue region within the oral cavity. The systems and methods resist posterior movement of the tongue within the oral cavity by coupling the first implant element to the second implant element within the oral cavity. By coupling, the systems and methods apply force, e.g., tension, between the first and second implant elements.

RELATED APPLICATION

This application is a division of U.S. patent application Ser. No.10/236,455, filed Sep. 6, 2002, and entitled “Systems and Methods forMoving and/or Restraining Tissue in the Upper Respiratory System.”

FIELD OF THE INVENTION

The invention is directed to systems and methods for moving and/orrestraining tissue in the upper respiratory system, e.g., for thetreatment of sleep-related breathing disorders such as snoring, upperairway resistance syndrome and obstructive sleep apnea.

BACKGROUND OF THE INVENTION

First described in 1965, sleep apnea is a breathing disordercharacterized by brief interruptions (10 seconds or more) of breathingduring sleep. Sleep apnea is a common but serious, potentiallylife-threatening condition, affecting as many as 18 million Americans.

There are two types of sleep apnea: central and obstructive. Centralsleep apnea, which is relatively rare, occurs when the brain fails tosend the appropriate signals to the breathing muscles to initiaterespirations, e.g., as a result of brain stem injury or damage.Mechanical ventilation is the only treatment available to ensurecontinued breathing.

Obstructive sleep apnea (OSA) is far more common. Normally, the musclesof the upper part of the throat keep the airway open to permit air flowinto the lungs. When the muscles of the soft palate at the base of thetongue and the uvula (the small fleshy tissue hanging from the center ofthe back of the throat) relax and sag, the relaxed tissues may vibrateas air flows past the tissues during breathing, resulting in snoring.Snoring affects about half of men and 25 percent of women—most of whomare age 50 or older.

In more serious cases, the airway becomes blocked, making breathinglabored and noisy, or even stopping it altogether. In a given night, thenumber of involuntary breathing pauses or “apneic events” may be as highas 20 to 30 or more per hour. These breathing pauses are almost alwaysaccompanied by snoring between apnea episodes, although not everyone whosnores has this condition. Sleep apnea can also be characterized bychoking sensations.

Lack of air intake into the lungs results in lower levels of oxygen andincreased levels of carbon dioxide in the blood. The altered levels ofoxygen and carbon dioxide alert the brain to resume breathing and causearousal. The frequent interruptions of deep, restorative sleep oftenlead to early morning headaches, excessive daytime sleepiness,depression, irritability, and learning and memory difficulties.

The medical community has become aware of the increased incidence ofheart attacks, hypertension and strokes in people with moderate orsevere obstructive sleep apnea. It is estimated that up to 50 percent ofsleep apnea patients have high blood pressure.

Upon an apneic event, the sleeping person is unable to continue normalrespiratory function and the level of oxygen saturation in the blood isreduced. The brain will sense the condition and cause the sleeper tostruggle and gasp for air. Breathing will then resume, often followed bycontinued apneic events. There are potentially damaging effects to theheart and blood vessels due to abrupt compensatory swings in bloodpressure. Upon each event, the sleeping person will be partially arousedfrom sleep, resulting in a greatly reduced quality of sleep andassociated daytime fatigue.

Although some apneic events are normal in all persons and mammals, thefrequency of blockages will determine the seriousness of the disease andopportunity for health damage. When the incidence of blockage isfrequent, corrective action should be taken.

The common method of diagnosing and determining the severity of sleepapnea is polysomnography. Polysomnography is a test that records avariety of body functions during sleep, such as the electrical activityof the brain, eye movement, heart rate, etc.

There are several methods and devices presently available for thetreatment of snoring and OSA. There are oral appliances which aredesigned to displace the mandible (lower jaw) in an anterior (forward)direction by attaching to the upper and lower teeth. The intent is todisplace the tongue in an anterior direction, increasing the size of theopening behind the tongue, resulting in an increased airway crosssection. These devices have been only partially successful and are nottolerated by a significant percentage of the patients who have themfitted.

Another means of controlling snoring and sleep apnea is the use of amachine that delivers increased air pressure to the nose and mouth ofthe sleeper. These machines are described as CPAP (Continuous PositiveAirway Pressure) machines. They entail wearing of a mask, headgear, andflexible hose which is attached to the air pump. A continuous flow ofair at higher than ambient air pressure is forced into the persons'airway, preventing closure of the soft tissue and the resultant apneicevent. These devices have also been shown to reduce snoring but notnecessarily prevent snoring entirely.

Although effective, the CPAP machine is not widely accepted by thepatients. Discomfort, the sound of the air pump, claustrophobia and thestigma of being seen while wearing the mask, headgear, and hose have allbeen listed as reasons for not continuing use of the CPAP.

Several surgical approaches are used for these afflictions. One is auvulopalatopharyngoplasty (UPPP) in which tissue at the posteriorportion of the soft palate is removed, either by surgical excision or byuse of a laser (so-called laser ablation) . This is an invasive surgicalprocedure involving considerable pain in the recovery period, which canbe lengthy. Side effects can involve escape of fluids upward into thenasal cavity and increased incidence of bothersome choking events. Thelong-term success of the UPPP in curing snoring and especially sleepapnea is only approximately 50%.

Other even more involved and invasive surgeries involve tongue reductionin which a section of the tongue is excised to reduce the tongue volumeand maxillomandibular advancement in which the upper and lower jaws aresevered and repositioned to create increased airway space will improveupon the UPPP success rates. Even more so than the UPPP, theseprocedures are painful, costly and require long recuperative periods.Absolute assurance of a successful outcome is lacking in theseoperations, also. An office-based procedure—called the Somnoplasty®procedure (developed by Somnus Medical Technologies) can be performedusing local anesthesia to treat upper-airway obstructions. The procedureuses controlled, low-power radio frequency energy to create one orseveral submucosal volumetric lesions in the soft palate. Over a periodof 6 to 8 weeks, the lesions are naturally resorbed, reducing tissuevolume and stiffening remaining tissue in the desired area.

Other more intrusive treatments such as surgical interventions, i.e.glossectomy (reduction of the size of the tongue 34), genioglossaladvancement (pulling the genioglossus muscle in an anterior direction tobring the tongue forward), maxillomandibular advancement (surgicalalteration of a portion of the jaw bone and teeth plus the portion ofthe skull to which the upper teeth are attached) anduvulopalatopharyngoplasty—UPPP (the removal of a portion of the softpalate, either by surgical resection or laser ablation) all permanentlymodify the anatomy and can affect swallowing, speech and comfort in anegative manner. Other proposed devices, such as implantation of springsand other stiffening devices, can also have an undesired effect ondaytime functions.

The need remains for simple, cost-effective devices and methods forreducing or preventing snoring and obstructive sleep apnea.

SUMMARY OF THE INVENTION

The invention provides systems and methods for selectively stabilizingtissue in the oral cavity. The systems and methods restrain movement ofmore mobile tissue within the oral cavity, e.g., the tongue, towardpositions in which snoring and/or sleep apnea events can occur.

According to one aspect of the invention, the systems and methodsinclude a first implant element sized and configured for implantation ina bone region within an oral cavity and a second implant element sizedand configured for implantation in a tongue region within the oralcavity. The systems and methods also include a third implant elementcoupled to the first and second implant elements within the oral cavity.The third implant element is capable of applying force between the firstand second implant elements such that the implant, in use, resistsposterior movement of the tongue within the oral cavity.

In one embodiment, the first implant element is sized and configured forimplantation in a mandible.

In one embodiment, the first implant element is sized and configured forimplantation in a hyoid bone.

In one embodiment, the third implant element includes a component thatapplies force between the first and second implant elements in responseto magnetic interaction with another component.

According to another aspect of the invention, the systems and methods,comprise a first implant element sized and configured for implantationin a bone region within an oral cavity and a second implant elementsized and configured for implantation in a tongue region within the oralcavity. According to this aspect of the invention, a third implantelement is coupled to the first and second implant elements within theoral cavity, which is capable of applying tension between the first andsecond implant elements such that the implant, in use, resists posteriormovement of the tongue within the oral cavity.

In one embodiment, the first implant element is sized and configured forimplantation in a mandible.

In one embodiment, the third implant element includes an elongatedmember that applies the tension.

According to another aspect of the invention, a method implants a firstimplant element in a bone region within an oral cavity and implants asecond implant element in a tongue region within the oral cavity. Themethod resists posterior movement of the tongue within the oral cavityby coupling the first implant element to the second implant elementwithin the oral cavity.

In one embodiment, the first implant element is implanted in a mandible.

In one embodiment, the first implant element is implanted in a hyoidbone.

According to another aspect of the invention, a method implants a firstimplant element in a bone region within an oral cavity and implants asecond implant element in a tongue region within the oral cavity. Themethod resists posterior movement of the tongue within the oral cavityby placing into tension a third implant element between the secondimplant element and the first implant element within the oral cavity.

In one embodiment, the first implant element is implanted in a mandible.

In one embodiment, the third element comprises an elongated memberplaced into tension between the first and second implant elements.

Other features and advantages of the invention shall be apparent basedupon the accompanying description, drawings, and claims.

DESCRIPTION OF THE DRAWINGS

FIG. 1 is an anatomical cross-section of a normal human nasal airway,oral cavity, and oropharynx.

FIG. 2 is a view similar to FIG. 1, illustrating occlusion of theoropharynx that occurs during obstructive sleep apnea.

FIG. 3A is an anatomical cross-section of a human nasal airway showingthe placement and interaction of primary and secondary magnets, bothfixed to surface tissue, to effect anterior movement of the soft palate.

FIG. 3B is an anatomical cross-section of a human nasal airway showingthe placement and interaction of a primary magnet implanted in tissueand a secondary magnet affixed to surface tissue to effect anteriormovement of the soft palate.

FIG. 4A is an anatomical cross-section of a human nasal airway showingpermanent primary magnet locations affixed to surface tissue of the softpalate and uvula.

FIG. 4B is an anatomical cross-section of a human nasal airway showingpermanent primary magnet locations implanted in tissue of the softpalate and uvula

FIG. 5A is an anterior view of a human oral cavity showing placement ofpermanent primary magnets affixed to surface tissue of the soft palateand at the root of the uvula.

FIG. 5B is an anterior view of a human oral cavity showing placement ofpermanent primary magnets implanted in tissue of the soft palate and atthe root of the uvula.

FIG. 6A is an oblique view of the primary magnet locations shown in FIG.5A.

FIG. 6B is an oblique view of the primary magnet locations shown in FIG.5B.

FIG. 7 is an anatomical view of human oral cavity and illustrating theconfiguration and placement of primary magnets on the uvula and softpalate.

FIG. 8 is a perspective view of a primary magnet shown in FIG. 7 andconfigured for attachment to the uvula.

FIG. 9 is a side view illustrating attachment of a primary magnet on theuvula using a stud and backing plate.

FIG. 10A is a front view of a primary magnet configured for attachmentto the soft palate.

FIG. 10B is a side view of the magnet shown in FIG. 10A.

FIG. 11 is a side view and illustrating the use of a stud to secure amagnet of the type shown in FIGS. 10A and 10B to a complementary backingpad.

FIG. 12A is a top perspective view of a soft pad oral appliance devicewith flexible, movable mounting stem and secondary magnet at the distalend which embodies features of the invention.

FIG. 12B is a bottom perspective view of the soft pad oral appliancedevice shown in FIG. 12A.

FIG. 13 is a side section view of the oral appliance shown in FIG. 12A.

FIG. 14 is an anatomical cross-section of a human upper airway showingthe use of a positioning tool to place the oral appliance of FIGS. 7 and8 within the oral cavity.

FIG. 15 is a perspective view of the positioning tool shown in FIG. 14.

FIG. 16 is an anatomical view of a human oral cavity illustrating theplacement of an alternative embodiment of an oral appliance embodyingfeatures of the invention within the oral cavity.

FIG. 17 is a bottom view of the oral appliance shown in FIG. 16.

FIG. 18 is a perspective view of the oral appliance shown in FIG. 16.

FIG. 19 is a perspective view of an alternative embodiment of the oralappliance shown in FIG. 18.

FIG. 20 is an anatomical cross-section of a normal human nasal airway,oral cavity, and oropharynx showing the placement of a primary magnetwithin the tongue to effect anterior movement of the tongue.

FIG. 21 is a top view of the tongue shown in FIG. 20 and illustratingthe placement of primary magnets in the opposing lateral margins of thetongue to effect anterior movement of the tongue.

FIG. 22 is a perspective view of an oral appliance embodying features ofthe invention.

FIG. 23 is an anatomical front view of a human oral cavity illustratingthe placement of the appliance of FIG. 22 over the bottom teeth.

FIG. 24 is a perspective view of an oral appliance embodying features ofthe invention.

FIG. 25 is an anatomical front view of a human oral cavity illustratingthe placement of the appliance of FIG. 24 over the upper teeth.

FIG. 26 is an anatomical cross-section of a human nasal airway showingthe placement of the appliances of FIGS. 22 and 24 within the oralcavity.

FIG. 27 is an anatomical cross-section of a human nasal airway showingan alternative embodiment of the oral appliance shown in FIG. 24.

FIG. 28 is an anatomical cross-section of a human upper airwayillustrating an alternative embodiment of the invention in which aprimary magnet is attached to the epiglottis and a secondary magnet iscarried by an external neck collar.

FIG. 29 is a perspective view of an alternative embodiment of the collarshown in FIG. 28.

FIG. 30 is an anatomical cross-section of a human upper airwayillustrating an alternative embodiment of the invention in which aprimary magnet is carried by a fulcrum attached to the hyoid bone and asecondary magnet is carried by an external neck collar.

FIG. 31 is an anatomical cross-section of a human upper airwayillustrating an alternative embodiment of the fulcrum shown in FIG. 30and its placement in tissue in front of and above the hyoid bone.

FIG. 32 is an anatomical cross-section of a human upper airwayillustrating an alternative embodiment of the invention in which aprimary magnet is carried by a device implanted into the mandible and asecondary magnet is carried by an external neck collar.

FIG. 33 is a side view of an alternative embodiment of the device shownin FIG. 32.

FIG. 34 is an anatomical cross-section of a human upper airwayillustrating an alternative embodiment of the invention in which aprimary magnet is carried by a device implanted into the mandible and asecondary magnet is carried by an external neck collar.

FIG. 35 is a perspective view of the device of FIG. 34 and illustratingupward movement of the lifting arm in response to anterior movement ofthe pull wire.

FIG. 36 is a cross-sectional view of the device of FIG. 35.

FIG. 37 is a view similar to FIG. 36 and illustrating the upward andforward movement of the lifting arm in response to the magnet beingpulled in a downward direction.

FIG. 38 is a perspective view of an oral appliance intended forplacement within the oral cavity and including a suction source toaffect anterior movement of the soft palate and/or uvula.

FIG. 39 is a top view of the suction source that is carried by theappliance shown in FIG. 38.

FIGS. 40A and 40B are side section views of the suction source shown inFIG. 39, being operated during use to affect anterior movement of thesoft palate and/or uvula.

FIG. 41 is an anatomical view of a human oral cavity illustrating theplacement of the oral appliance shown in FIG. 38 to affect anteriormovement of the soft palate and/or uvula.

FIG. 42 is a perspective view of an oral appliance intended forplacement on the bottom teeth within the oral cavity and including asuction source to affect anterior movement of the tongue.

FIG. 43 is an anatomical view of a human oral cavity illustrating theplacement of the oral appliance shown in FIG. 42 to affect anteriormovement of the tongue.

DETAILED DESCRIPTION

Although the disclosure hereof is detailed and exact to enable thoseskilled in the art to practice the invention, the physical embodimentsherein disclosed merely exemplify the invention which may be embodied inother specific structure. While the preferred embodiment has beendescribed, the details may be changed without departing from theinvention, which is defined by the claims.

I. Anatomy of the Upper Respiratory System

FIG. 1 illustrates the normal anatomy of the human upper respiratorysystem, which communicates with the trachea 10 and the lower respiratorysystem through the larynx 12. In humans, the pharynx is divided intonasal, oral, and laryngeal portions. The nasopharynx 14 lies posteriorto the nasal cavity 16. The oropharynx 18 communicates with thenasopharynx 14 superiorly, the oral cavity (mouth) 20 anteriorly, andthe laryngopharynx 22 inferiorly. The laryngopharynx 22 lies posteriorto the larynx 12 and serves as the entrance to the esophagus 24.

The upper part of the oral cavity 20 is the palate 26, and it separatesthe oral cavity 20 from the nasal cavity 16. The anterior two-thirds ofthe palate 26 is the bony hard palate 28. The movable posterior third ofthe palate 26, made up of muscle and aponeurosis, is known as the softpalate 30. The soft palate 30 is suspended from the posterior border ofthe hard palate 28 and extends posteroinferiorly as a curved free marginfrom which hangs a conical process, the uvula 32. The tongue 34 islocated over the floor of the oral cavity 20. The epiglottis 33 is athin leaf-shaped structure immediately posterior to the base of thetongue 34. The epiglottis 33 covers the entrance of the larynx 12 whenan individual swallows, thereby preventing food or liquids from enteringthe airway. These structures are all interrelated in the functions ofbreathing, swallowing and speech.

With reference to FIG. 2, during sleep, the soft palate 30 and uvula 32,being unsupported by bone or cartilage, can droop into the airway andvibrate, resulting in loud snoring. A similar situation exists in whichthe tongue 34 can become relaxed and move in a posterior direction,partially or fully obstructing the airway. This condition can cause ahypopnea, in which the airway is partially obstructed, making breathingmore difficult, or apnea, in which the airway is completely obstructed.Sleep apnea, and to a lesser degree, hypopnea can have extremely serioushealth consequences.

As FIG. 2 illustrates, the soft palate 30 and uvula 32 may actually comein contact with the posterior wall of the oropharynx 18. In addition,the back of the tongue 34 may come to lie near the posterior wall of theoropharynx 18. Because of the narrowed space, the velocity of the airpassing through the airway will be affected and the soft palate 30 canvibrate and/or flutter during respiration, emitting a loud sound(snoring). This can happen with or without the tongue 34 being in therearward position shown in FIG. 2.

The tongue 34 can also fall toward the rear of the mouth 20 andpartially or fully obstruct the airway. At the end of exhalation and thebeginning of inhalation is the point at which the tongue 34 and/or softpalate 30 can stop the airflow within the airway, resulting in an apneicevent. If the airway is partially obstructed, an hypopnea can occur.

Therefore, as indicated by arrows in FIG. 2, the desirable forces andtissue location are in an anterior direction. If the soft palate 30 andthe tongue 34 are moved and retained as shown during sleep, the airwaywill remain unrestricted and the tendency for the soft palate 30 tovibrate or flutter will be reduced or eliminated entirely.

II. System Overview (Primary Magnet Configured for Anterior Movement ofSoft Palate and/or Uvula)

FIGS. 3A and 3B illustrate alternative embodiments of a system fortreating sleep-related breathing disorders such as snoring, upper airwayresistance syndrome and obstructive sleep apnea. The system employs atleast one primary magnet 36 and at least one secondary magnet 38.Together, the magnets 36 and 38 serve to position, stabilize andmaintain a preferred orientation of tissue in an oral cavity and airwayin both humans and animals. By moving and stabilizing tissue in adesired location and shape, the system mediates or prevents theobstruction of the upper airway that results in sleep-related breathingdisorders. Still, as will be described, the system achieves theseresults without permanent modification of the anatomy.

An object that exhibits magnetic properties (i.e., magnetism) is calleda magnet. Magnetism is a force of attraction or repulsion betweenvarious substances, especially those made of iron and certain othermetals, ultimately due to the motion of electric charges. Every magnethas a magnetic field, which is a region around the magnet in which themagnetic effects are observed. In the illustrated embodiment, theprimary and secondary magnets 36 and 38 are desirably permanent magnets,i.e., they maintain an essentially constant magnetic field over time.

The magnets 36 and 38 possess poles of opposite polarity. The poles arecenters where magnetic attraction is strongest. If the magnet is free toturn, one pole will point north, and is thus called a North pole, andthe opposite pole is likewise called a South pole. According to physicallaws, poles of like polarity (North-North or South-South) repel eachother with a magnetic force. On the other hand, poles of unlike polarity(North-South or South-North) attract each other with a magnetic force.The force of magnetic attraction or repulsion depends on the strength ofthe magnets and the distance between the poles.

In the alternative embodiments illustrated in FIGS. 3A and 3B, theprimary and secondary magnets 36 and 38 are mutually oriented so thatthe force of magnetic attraction draws the primary magnet 36 toward thesecondary magnet 38. That is, the primary magnet 36 is of oppositepolarity from the secondary magnet 38, e.g., the primary magnet 36 is ofNorth polarity and the secondary magnet 38 is of South polarity, or viceversa. In this Specification, such an orientation of magnetic poles iscalled “complementary.”

In this arrangement, the secondary magnet 38 is intended to be carriedin or by relatively immobile tissue, or at least mounted more securelythan the primary magnet 36. The primary magnet 36 is intended to becarried in or by mobile tissue. Thus, as the more mobile primary magnet36 is drawn toward the less mobile secondary magnet 38, a desiredmovement of tissue occurs.

It should be appreciated that either magnet 36 or 38 may exert amagnetic force on a material that is not magnetized. Therefore, one ofthe magnets 36 or 38 can be replaced by a material, e.g., ferrous plate,on which the remaining magnet 36 or 38 is able to exert an attractivemagnetic force. Of course, a ferrous plate could not exert a repellingforce without itself being magnetized. The terms “primary magnet(s)” or“secondary magnet(s)” as used in this specification are therefore notlimited to an object that exhibits magnetic properties (i.e., an objectthat is magnetized), but also encompass an object made of a materialthat is not itself magnetized but which is attracted to another objectthat is magnetized. Still, use of the terms requires that at least oneof the “primary magnet(s)” or “secondary magnet(s)” comprise an objectthat is magnetized.

In FIGS. 3A and 3B, the primary magnet 36 is carried by more mobiletissue of the soft palate 30, e.g., at the root of the uvula 32. In FIG.3A, the primary magnet 36 is attached to surface tissue at the root ofthe uvula 32. In FIG. 3B, the primary magnet 36 is implanted in tissueat the root of the uvula 32. In either situation, the portion(s) of theprimary magnet 36 contacting tissue (either surface or subsurface)desirably includes a biocompatible coating to prevent interactionbetween the magnet and tissues/fluids of the body. The secondary magnet38 is carried by an oral appliance magnet holder 40, which is carried byless mobile tissue (i.e., the upper teeth) along the roof of the mouth.Technical features of the holder 40 will be described in greater detaillater.

Arranged in a complementary manner, the less mobile secondary magnet 38acts upon the more mobile primary magnet 36 to draw the primary magnet36, and, with it, the mobile tissue of the soft palate 30, in ananterior direction (depicted by phantom lines in FIG. 3A and FIG. 3B) toprevent obstruction of the airway.

As will be demonstrated, the primary and secondary magnets 36 and 38 canbe sized, configured, and placed in a variety of arrangements to effectthe desired positioning of tissue. Depending upon the degree offlexibility or firmness of the palate 26, the physician may attach oneor several primary magnets 36 to the soft palate 30 and variations inthe oral appliance 40 can accommodate the variation in the number andposition of the magnets 36.

As will be discussed later, in alternative arrangements, the primary andsecondary magnets 36 and 38 may be mutually oriented so that the forceof magnetic attraction repels the magnets 36 and 38 away from eachother. That is, the primary magnet 36 is of the same polarity from thesecondary magnet 38, e.g., the primary and secondary magnets 36 and 38are both of North polarity or South polarity. In this Specification,such an orientation of magnetic poles is called “non-complementary.” Inthis arrangement, the secondary magnet 38 is still intended to becarried in or by relatively immobile tissue, while the primary magnet 36is intended to be carried in or by mobile tissue. Thus, the more mobileprimary magnet 36 is repelled away from the less mobile secondary magnet38, and a desired movement of tissue occurs.

A. The Primary Magnet(s)

FIGS. 4A and 4B show alternatively implementation of a representativeembodiment, in which two primary magnets 36 are attached to the anteriorsurface of the soft palate 30 and root of the uvula 32 respectively. InFIG. 4A, the magnets 36 are removably attached to exterior tissue usingstuds 42 that are fitted into pierced holes 44 in the tissue and aresecured by a retaining lock device, e.g., a backing plate 46 on theposterior surface of the soft palate 30. The backing plate 46 isdesirably made of silicone or a similar biocompatible elastomericmaterial. Alternatively, as seen in FIG. 4B and FIG. 14, the primarymagnets 36 may be implanted within the soft palate 30. The portion(s) ofthe primary magnet 36 contacting tissue (either surface or subsurface)desirably includes a biocompatible coating to prevent interactionbetween the magnet and tissues/fluids of the body.

FIGS. 5A/5B and 6A/6B show alternative arrangements of primary magnets36 in the soft palate 30. In this arrangement, a primary magnet 36A isattached to the soft palate 30 at approximately the base of the uvula32. A pair of additional primary magnets 36B are positioned in the softpalate 30 anterior to and radially from the first primary magnet 36A ina triangular configuration. In FIGS. 5A and 6A, the primary magnets 36are attached to surface tissue at the base of the uvula 32. In FIG. 5Band 6B, the primary magnets 36 are implanted in tissue at the base ofthe uvula 32. As before stated, the portions of the primary magnets 36contacting tissue (either surface or subsurface) desirably includes abiocompatible coating to prevent interaction between the magnet andtissues/fluids of the body.

FIGS. 7 to 11 detail representative embodiments of soft palate primarymagnets 36A and 36B. FIG. 7 shows a primary magnet 36A configured forattachment to the uvula 32 and primary magnets 36B configured forattachment to the soft palate 30 adjacent the uvula 32.

As best seen in FIG. 8, the front side 48 and the back side 50 of themagnet 36A provide a concave, or sectorial, configuration, toapproximate the contour of the anterior surface of the uvula. A screwstud hole 44A permits passage of the stud 42 to allow attachment of themagnet 36A to the uvula 32. The edges of the magnet 36A are desirablyrounded or radiused, to prevent irritation of surrounding tissue. Thisprovides increased comfort to the individual.

As seen in FIG. 9, the magnet 36A is placed on the anterior surface ofthe uvula 32. A stud 42 is passed through the screw stud hole 44A andthe magnet 36A is secured in place by the backing plate 46A.

As FIGS. 10A and 10B show, the soft palate primary magnets 36B have abowed configuration to approximate the contour of the arch of the softpalate 30, e.g., kidney bean shape. Similar to primary magnet 36A,rounded or radiused edges are provided to prevent irritation ofsurrounding tissue.

With reference to FIG. 11, a conformal backing plate 46B serves tosecure attachment of the magnet 36B to the soft palate 30. In thearrangement shown in FIG. 11, the plate 46B includes a pair of pins 54(left and right), each pin having a bore 56 to receive and secure a stud42, e.g., by threaded engagement. The magnet 36B includes a pair ofscrew stud holes 52B (left and right) that register with the pins 54.The holes 52B are desirably tapered and configured to receive the pins54 and permit passage of studs 42 to secure attachment of the magnet36B.

B. Oral Appliances for Removably Mounting the Secondary Magnet in theOral Cavity

1. FIRST EMBODIMENT

Referring now to FIGS. 12A, 12B, and 13, the system includes an oralappliance 40 to carry the secondary magnet 38 within the oral cavity 20.Desirably, the oral appliance 40 is configured for convenient temporaryplacement into and removal from the oral cavity 20.

As before explained, the secondary magnet 38 is complementary to theprimary magnet 36, i.e., the primary and secondary magnets 36 and 38 areof opposite polarity.

As shown in FIGS. 12A and 12B, the appliance 40 comprises a base pad 58and a support stem 60. The support stem 60 carries one or more secondarymagnets 38 on its far end. As seen in FIG. 12B, the bottom surface ofthe appliance 40 includes positioning holes 62, the function of whichwill be described later.

The bottom surface also carries a slidable knob 64, which forms the nearend of the support stem 60. As FIG. 13 shows, the knob 64 works againsta spring 68 within the base pad 58. The spring 68 biases the supportstem 60 and secondary magnet 38 toward an anterior position in the oralcavity 20. The spring 68 nevertheless accommodates transitory movementof the secondary magnet 38 toward a more posterior direction. Moreparticularly, the spring 68 allows the secondary magnet 38 to followtransitory anterior-posterior movement of the more mobile primary magnet36, e.g., during swallowing, while still urging the primary magnet 36,and, with it, the mobile tissue attached to it, toward a desiredanterior position.

In use, as shown by an arrow in FIG. 3, the knob 64 can be manipulatedby the wearer to slide the secondary magnet 38 toward the rear of themouth 20, and thus toward the primary magnet(s) 36 affixed to the softpalate 30. As attraction between the magnets 36 and 38 occurs, thewearer can release the knob 64. When released, the spring 68 urges thestem 60 (and secondary magnet 38) toward an anterior position within themouth 20. The tissue of the soft palate 30 and uvula 32 are therebyurged forward toward a desired anterior position, as depicted by phantomlines in FIG. 3, to prevent the tissue of the soft palate 30 fromfalling back into the airway.

The spring 68 is designed to place a light pulling force in the range of2 to 50 grams on the primary magnet(s) 36 affixed to the soft palate 30.It is believed that these low pulling forces are sufficient. The lightpulling forces further provide comfort to the wearer and avoidirritation to the tissue.

The base 58 of the appliance 40 can be constructed of a resilient, softelastomeric material such as silicon rubber, or may alternatively bemade of a closed-cell polymeric foam. These soft materials allow thebody of the device to conform to the roof of the mouth 20, which canvaries greatly among individuals. The base 58 can be positioned withinthe oral cavity 20 and attached to the roof of the mouth 20 using ahigh-tack adhesive compatible with the oral cavity 20, such as that usedto secure dentures to gums.

Desirably, the interior surface of the bore 70 (see FIG. 13), in whichthe stem 60 and the spring 68 are positioned, is injection molded of arigid, thermoplastic material such as ABS, acetal, or polypropylene toprovide smooth sliding action for the stem 60. The appliance 40 may beovermolded by the soft material of the base pad 58, or the appliance 40may be inserted and bonded into a recess in the base pad 58. This hybridstructure for the appliance 40 provides dimensional integrity needed toprevent binding of the moving parts, which might result from having thebore 70 located directly in the compliant material, while neverthelessallowing the base 58 to be soft and conformable enough to fit a widevariation in shape and contour of the roof of the mouth 20.

In use, the opposing pole magnets 36 and 38 may make physical contactwith each other. Alternatively, the opposing pole magnets 36 and 38 maybe positioned so that they are magnetically attracted to one anotherwithout physical contact.

There may be one or more primary magnets 36 attached to the uvula 32and/or soft palate 30, as previously described and as shown in FIGS. 4and 5.

The appliance 40 is desirably configured for easy insertion into andremoval from the oral cavity 20 by the wearer. Thus, the appliance 40may be used only during sleep and removed upon awakening. Removal of theappliance 40 during waking hours prevents any interference withswallowing, speech, or other routine activities.

A physician can initially fit the appliance 40 to an individual's mouth20. The physician visually determines the appropriate position withinthe mouth 20 to properly pull the soft palate 30 and uvula 32 in ananterior direction and to the desired degree. To aid the individual tosubsequently position the appliance 40 within the mouth 20, apositioning tool 72 is desirably supplied with the appliance 40.

FIGS. 14 and 15 show a representative embodiment for a positioning tool72 suitable for this purpose. The tool 72 desirably includes a handle74. The handle 74 can be molded integrally with a carrier back 76, whichextends for the entire length of the tool 72.

A center pointer 78 is molded as a part of a slider 80. The fore and aftposition of the slider 80 is desirably fixed by the physician whencustomizing the tool 72 to the individual, as represented by arrow 81 inFIG. 15. A locking tab 82 holds an interior locking pin 84. When thephysician sets the slider 80 in the desired location, the locking tab 82can be withdrawn, allowing the internal locking pin 84 to engageopenings 86 in the carrier back 76. The slider 80 is thereby permanentlyset by the physician in the desired position customized for theindividual.

Notches 88 and upright fingers 90 form a receiver for the lateralincisors, to provide a positioning feature that allows the tool 72 toaccurately place the base 58 of the appliance 40 in the roof of themouth 20. A rotatable member 92 pivots about a pivot pin 94 and issubject to a light friction to prevent undesirable rotation.

The tool 72 further includes a pair of positioning pins 96, which extendfrom the rotatable member 92. The pins 96 register with and enter thepositioning holes 62 on the appliance 40, as previously described. Thepatient places the base 58 on the tool 72 by pressing the base 58 ontothe pins 96 to engage the positioning holes 62 with the pins 96. Theelastic nature of the compliant material in the base 58, along with ahole diameter slightly smaller than the diameter of the standing pins96, causes the base 58 of the appliance 40 to be frictionally held onthe rotatable member 92.

Once the appliance 40 is fitted to the positioning tool 72, the patientapplies a prescribed amount of adhesive (not shown) to the top surfaceof the base 58. Manipulating the positioning tool 72 like a tonguedepressor, the individual positions the tool 72 in the oral cavity 20(see FIG. 14).

While standing in front of mirror, the individual aligns the pointer 78with the interdental space between the two upper incisors. Theindividual also brings the notches 88 into contact with the occlusalsurface of the lateral incisors, with the upright fingers 90 pressingagainst the anterior surface of the upper teeth(because the physicianhas previously adjusted the center pointer 78 to the appropriate foreand aft position, as previously described, it is not necessary for theindividual to make any further adjustments).

With the handle 74 held horizontally (depicted in solid lines in FIG.14), the individual holds the positioning tool 72 against the upperteeth. The individual pivots the exposed handle end 74 of the tool 72downward (as depicted by the arrow and phantom lines in FIG. 14). Thefar end 98 of the appliance 40 swings in an upward arc toward the roofof the mouth 20, as represented by phantom lines in FIG. 14. As theappliance 40 moves upward, the stem 60 of the appliance 40 makes contactwith the hard palate 28 at a desired point 100. This causes therotatable member 92 to swing (depicted by arrow 99 in FIG. 15) bringingthe top surface of the base 58 (with the dental adhesive material) intoan orientation that is parallel to the roof of the mouth 20, and in aposition selected by the physician when the appliance 40 was originallyfitted.

After holding a light pressure upward for a short time period, e.g.,approximately 10 seconds, the individual pulls the positioning tool 72downward to release it from the base 58, leaving the appliance 40affixed to the roof of the mouth 20 in the desired position. Uponremoving the tool 72, the individual can use a thumb or finger to pressthe base 58 into intimate contact with roof of the mouth 20 and set thebond.

Referring again to FIG. 3, the patient then places a finger on the knob64 to move the knob 64 as depicted by an arrow in FIG. 3 toward the backof the mouth 20 to bring the primary magnet(s) 36 into attraction withthe secondary magnet(s) 38, thereby pulling the soft palate 30 and uvula32 into a forward, stabilized position.

To remove the appliance 40, the patient uses a fingertip to peel theflexible base 58 away from the roof of the mouth 20. In one embodiment(see FIGS. 12A and 12B), the anterior end 101 of the appliance 40 caninclude a groove or chamfer 102 to facilitate peeling the base pad 58away from the roof of the mouth 20, as also shown in FIG. 14. Theremaining adhesive can be removed by brushing with a toothbrush. Toreuse the appliance 40, the patient peals off the remaining adhesiveattached to the base 58 by using a fingertip to roll the adhesive off ofthe top surface of the base 58.

The appliance 40 may, alternatively, be of a modular design, allowingthe soft compliant base 58 to be a disposable component into which thetool 72 may be placed and withdrawn for re-use the next night. Thedisposable base 58 may contain a pressure sensitive adhesive toeliminate the need to use and apply a liquid adhesive.

2. SECOND EMBODIMENT

FIGS. 16 to 18 show another representative embodiment of an appliance104 that can be releasably mounted in the oral cavity 20, to hold one ormore secondary magnets 38 in alignment with one or more primary magnetscarried by the soft palate and/or uvula.

In this arrangement, secondary magnets 38C and 38D are mounted on a stemportion 106 having a knob 108 at the anterior end 110 of the appliance104. The secondary magnet 38C is positioned at the posterior end 112 ofthe stem 106 and is complementary to primary magnet 36C attached to theuvula 32 (see FIG. 16). Desirably, a pair of secondary magnets 38D alsoextend radially from the stem 106, just posterior to the secondarymagnet 38C. The secondary magnets 38D align with and complement theprimary magnets 36D attached to the soft palate 30.

Spring wires 114 extend radially from the stem 106. In this embodiment,the appliance 104 is held in place by use of an elastic band 116. Inuse, the band 116 is stretched around the outer faces of the upperteeth. The appliance 104 can also be anchored at the posterior surfaceof the molars by a pair of hooks 118 which couple with the spring wires114.

Indexing locators 120 can be provided to permit the position of thehooks 118 to be adjustable posteriorly and anteriorly for proper fit.The indexing locators 120 may be adjusted by the physician to fit intothe interdental spaces between the molars and then locked in place toprovide a repeatable positioning of the appliance 104. As best seen inFIG. 18, a series of holes 122 are desirably provided for easyadjustment of the locators 120.

When in place, the appliance 104 is positioned to permit an attractionbetween the opposing magnetic poles and pull the tissue of the softpalate 30 and uvula 32 in an anterior direction, as depicted by arrowsin FIG. 16.

As shown in FIG. 19, the hooks 118 may be replaced by molded trays 124into which the patient may place a small amount of dental adhesive (notshown) . In this embodiment, the band 116 is desirably a non elasticmaterial such as a nylon with a soft covering, preferably a siliconerubber. The patient slips the band 116 of the appliance 104 over thefront surface of the upper teeth and with the dental adhesive already inthe molded trays 124, presses the trays 124 upward into intimate contactwith the upper rear molars.

It should be appreciated that the oral appliance for holding one or moresecondary magnets in alignment with one or more primary magnets, carriedby the soft palate and/or uvula, can be custom formed to theindividual's hard palate. This arrangement would make possible anestablished and familiar way of placing a dental/oral appliance in themouth.

3. THIRD EMBODIMENT

FIGS. 24 and 25 show another alternative embodiment of an oral appliance142 that can be releasably mounted in the oral cavity 20, to hold one ormore secondary magnets 38 in alignment with one or more primary magnetscarried by the soft palate and/or uvula.

In this embodiment, the appliance 142 comprises a generally U-shapedbody 144. One or more secondary magnets 38 are carried by a bar 146extending from slots 148 on the medial surface of the body 144.

The body 144 is a generally hollow body having an open top 136 and openends 138, sized and configured to rest on the upper teeth, as seen inFIG. 25. Placement of the appliance 142 on the upper teeth results inattractive magnetic forces (represented by an arrow in FIG. 25) betweenthe primary and secondary magnets 36 and 38, drawing the primary magnet36 toward the secondary magnet 38, thereby pulling the uvula 32 and softpalate 30 into a forward, stabilized position.

The bar 146 can be configured for adjustment by anterior or posteriormovement, as represented by phantom lines in FIG. 24. This adjustmentpermits the secondary magnet 38 to be positioned properly in relation tothe primary magnet 36 to effect the desired movement of tissue. In theillustrated embodiment, the slots 148 have a ratcheted surface 150 onwhich the bar 146 may be moved in fore and aft directions. Of course,other mechanisms may be used to provide such movement.

III. Another System Overview (Primary Magnet Configured for AnteriorMovement of the Tongue)

As previously discussed, the tongue 34 is frequently the primary causeof apneic events. During sleep, tongue muscles can relax and allow thetongue 34 to move in a posterior direction and contact the pharyngealwall, occluding the oropharynx 18 (see FIG. 1). If the tongue 34 is inthe position described at the point of completing the exhalation cycle,it can act as a check valve, preventing inhalation.

FIGS. 20 to 23 illustrate one embodiment of another system for treatingsleep-related breathing disorders such as snoring, upper airwayresistance syndrome and obstructive sleep apnea. The system includes atleast one primary magnet 36′ implanted or otherwise affixed to thetongue 34, which can be used in association with a complementarysecondary magnet 38′ to position, stabilize and maintain the tongue in apreferred orientation in the oral cavity and airway, in both humans andanimals. By moving and stabilizing the tongue in a desired location, thesystem mediates or prevents the obstruction of the upper airway thatresults in sleep-related breathing disorders.

In the embodiment illustrated in FIGS. 20 to 23, the primary magnet 36′is of opposite polarity from the secondary magnet 38′, e.g., the Northpole of the primary magnet 36 is oriented to face the South pole of thesecondary magnet 38, or vice versa. The primary and secondary magnets36′ and 38′ are therefore complementary, i.e., they are mutuallyoriented so that the force of magnetic attraction draws the primarymagnet 36′ toward the secondary magnet 38′.

As previously described, the secondary magnet 38′ is intended to becarried in or by relatively immobile tissue, or at least mounted moresecurely than the primary magnet 36′. The primary magnet 36 is intendedto be carried in or by more mobile tissue. Thus, as the more mobileprimary magnet 36′ is drawn toward the less mobile secondary magnet 38′,a desired movement of tissue occurs.

It should again be appreciated that either magnet 36′ or 38′ may exert amagnetic force on a material that is not magnetized. Therefore, one ofthe magnets 36′ or 38′ can be replaced by a material, e.g., ferrousplate, on which the remaining magnet 36′ or 38′ is able to exert anattractive magnetic force. Of course, a ferrous plate could not exert arepelling force without being magnetized.

In FIGS. 20 to 23, the primary magnet 36′ is carried by the more mobiletissue of the tongue 34. The secondary 38′ is carried by an oralappliance 126, which is releasably mounted to less mobile tissue (i.e.,the lower teeth) along the floor of the mouth. Technical features of theholder 126 will be described in greater detail later.

Arranged in a complementary manner, the less mobile secondary magnet 38′acts upon the more mobile primary magnet 36′ to draw the primary magnet36, and, with it, the tongue 34, in an anterior direction (depicted byarrows in FIG. 23) to prevent obstruction of the airway.

A. Primary Magnet(s)

FIGS. 20 and 21 show a representative embodiment in which two primarymagnets 36′ are implanted in the opposing lateral margins of the tongue34. The secondary magnet 38′ is carried by an oral appliance 126 andinteracts with the primary magnet 36′ to effect anterior movement of thetongue 34 (see, e.g., FIG. 22). Sutures, bands or strips 128 can beimplanted into the posterior of the tongue 34 and fastened to themagnets 36′ to help pull the tongue 34 forward and distribute the forcesof magnetic attraction more evenly within the tongue 34.

The magnets 36′ can be coated with a fibrous or textured polymer layerto promote in growth of tissue into the coating. Tissue in growth willhelp to anchor the magnets 36′ and reduce the possibility of migrationof the magnets 36′ caused by pulling forces.

B. Oral Appliances for Removably Mounting Secondary Magnet(s) within theOral Cavity

FIGS. 22 and 23 illustrate one embodiment of an oral appliance 126 thatcan be releasably mounted in the oral cavity 20, to hold one or moresecondary magnets 38′ in alignment with one or more primary magnets 36′implanted within the tongue 34, to affect anterior movement of thetongue 34. The oral appliance 126 can be variously configured to permitconduction of magnet forces between the primary and secondary magnets36′ and 38′.

Like the appliance 40, the appliance 126 is desirably configured foreasy insertion and removal, so that it may be used only during sleep andremoved upon awakening. Removal of the appliance 40 during waking hoursprevents any interference with swallowing, speech, or other routineactivities.

The appliance 126 comprises a generally U-shaped body 130 and a pair ofsecondary magnets 38′ (right and left) carried by arms 132 extendingfrom connectors 134 on the medial surface of the body 130.

The body 130 is a generally hollow body having an open bottom 136 andopen ends 138, sized and configured to rest on the bottom teeth, as seenin FIG. 23. Placement of the appliance 126 on the bottom teeth alignswith secondary magnets 36′ with the primary magnets 34′. This results inattractive magnetic forces (represented by arrows in FIG. 23) betweenthe primary and secondary magnets 36′ and 38′. The complementary magnets36′ draw primary magnets 36′ toward secondary magnet 38′, therebypulling the tongue 34 into a forward, stabilized position.

The arms 132 can be configured for adjustment by anterior or posteriormovement. This adjustment permits the secondary magnets 38′ to bepositioned properly in relation to the primary magnets 36′ to effect thedesired movement of tissue. In the illustrated embodiment, the connector134 has a ratcheted surface 140 on which the arm 132 may be moved inanterior and posterior directions. Of course, other mechanisms can beused to provide this adjustment.

FIG. 26 illustrates the use of the upper appliance 142 previouslydiscussed and shown in FIGS. 24 and 25) in combination with the lowerappliance 126. As FIG. 26 shows, the upper appliance 142 acts to effectanterior movement (depicted by an arrow) of the soft palate 30 and uvula32. The lower appliance 126 acts to effect anterior movement (depictedby an arrow) of the tongue 34. In this arrangement, the appliances 126and 142 cooperate to maintain a desired position of the soft palate 30,uvula 32, and tongue 34 to mediate or prevent obstruction of the upperairway that results in sleep-related breathing disorders.

In another alternative embodiment, shown in FIG. 27, a single appliance152 carries both secondary magnets 38 and 38′. The appliance 152 isconfigured for placement over the upper teeth and is similar to theembodiment of the appliance 142 shown in FIGS. 24 and 25. However, apair of secondary magnets 38′ (right and left) are carried by arms 132extending from connectors 134 on the medial surface of a U-shaped body152 similar to the embodiment shown in FIGS. 23 and 24. Thus, in thisarrangement, a single appliance serves to effect movement of the softpalate 30, uvula 32, and tongue 34 to mediate obstruction of the upperairway that results in sleep-related breathing disorders.

IV. Another System Overview (Primary Magnet Attached to Epiglottis withExternal Secondary Magnet)

FIGS. 28 and 29 illustrate one embodiment of another system for treatingsleep-related breathing disorders such as snoring, upper airwayresistance syndrome and obstructive sleep apnea. The system includes atleast one primary magnet 156 affixed to the epiglottis 33, which is usedin association with a complementary secondary magnet 38 to position,stabilize and maintain the tongue in a preferred orientation in the oralcavity and airway in both humans and animals. The complementary magneticforces serve to support and move the tongue 34 forward to preventcontact between the back of the tongue 34 and the pharyngeal wall, thuspreventing occlusion of the airway.

As previously described, the secondary magnet 38′ is intended to becarried in or by relatively immobile tissue, or at least mounted moresecurely than the primary magnet 36′. In the illustrated embodiment, thesecondary magnet 36 is carried by a collar 158 worn externally about theneck. The primary magnet 156 is intended to be carried in or by mobiletissue. In the illustrated embodiment, the primary magnet 156 is affixedto the epiglottis. Thus, as the more mobile primary magnet 156 is drawntoward the less mobile secondary magnet 38, a desired movement of tissueoccurs.

A. Primary Magnet(s)

In the illustrated embodiment, the primary magnet 156 comprises aferrous plate 156 that is attached to the anterior surface of theepiglottis 33 and secured by a stud 42 and a flexible backing 46. Aspreviously described, the ferrous plate 156 may alternatively be amagnet of metallic or rare earth composition. Thus, the plate 156functions similar to primary magnet 36 previously described.

Multiple studs 42 may be used to affix the plate 156 (or magnet 36) tothe epiglottis 33. Alternatively, the ferrous plate 156 (or magnet 36)may be implanted within tissue of the epiglottis 33.

The backing 46 is desirably thin, e.g., approximately 1 mm, and taperedat the edges to avoid catching food particles or causing discomfort tothe patient. The means of securing the plate 156, stud 42, and backing46 is preferably a releasable connection, such as a threaded screw andtapped hole or other secure means that can be removed by the physician.

B. Secondary Magnet(s)

A collar 158, carrying a secondary, focused energy magnet 38 similar infunction to secondary magnets 38 previously described, is provided forwear during sleep. The collar 158 is desirably made of a webbing orother flexible belt-like material that is comfortable to the individualwearing it. For added patient comfort and convenience, the collar 158 ispreferably covered in a soft cloth sleeve that may be slipped off of thecollar and washed. Alternatively, a disposable cover (not shown) or anentirely disposable collar 158 may be employed.

The collar 158 may, in one embodiment, have an expandable (elastic)section, or it may be made entirely of an elastic belt material, so thatthe collar 158 may be comfortable and still provide stability for themagnet 38 mounted at the center front of the collar 158. The collar 158is equipped with a means for adjusting to a wide range of neck sizes.Such adjustment may be by belt, buttons or snaps, but in the preferredembodiment would use a hook and loop fastener such as Velcro® to provideadjustability.

The focused energy magnet 38 is positioned within a soft casing 160,preferably of a polymer foam, and further attached to a mounting bracket162, e.g., by adhesive or fastener 164. The mounting bracket 162 issecured to the adjustable collar 158, e.g., by adhesive or fastener 166,and positioned below the chin 165. The magnet 38 is of a high energytype, such as neodymium, and is sized and shaped to concentrate themagnetic flux in one direction. The magnet 38 may be encased in ashielding material to further focus and direct the magnetic force towardthe ferrous plate 156.

The collar 158 maintains the magnet 38 at a distance D1 from the plate156 and in position, to permit an attraction between the plate 156 andthe magnet 38. The magnet 38 is oriented with the primary direction ofmagnetic flux being in a posterior-anterior direction, as depicted byarrows in FIG. 28. Due to the collar mounting bracket 162, the magnet 38is held more securely in place than the plate 156. Therefore, attractivemagnetic forces draw the plate 156 toward the magnet 38. In thisarrangement, as the plate 156 is drawn forward toward the magnet 38, itplaces pressure on base of the tongue 34, thereby moving the tongue 34in an anterior direction.

In an alternative embodiment, the magnet 38 may be an electromagnet forexerting an adequate pull at the distance required to effect properpositioning of the tongue 34. Such an electromagnet may be powered by aD.C. power supply or by a battery pack.

As shown in FIG. 29, the collar 158 may extend upward and sweep backbehind the jaw 167, to prevent rotation of the collar 158 during sleep.

V. Overviews of Other Systems

A. Hyoid Bone Attachment

FIG. 30 shows another system for treating sleep-related breathingdisorders such as snoring, upper airway resistance syndrome andobstructive sleep apnea. The system includes at least one primary magnet36 implanted by surgical attachment to the hyoid bone 170, which is usedin association with a complementary secondary magnet 38 externally wornon the chin, to position, stabilize and maintain the tongue in apreferred orientation in the oral cavity and airway in both humans andanimals. The complementary magnetic forces serve to support and move thetongue 34 forward to prevent contact between the back of the tongue 34and the pharyngeal wall, thus preventing occlusion of the airway.

The system shown in FIG. 30 includes a device 168 sized and configuredto be implanted by surgical attachment to the hyoid bone 170 (the hyoidbone 170 is a horseshoe-shaped bone of anterior neck located at the baseof the tongue 34).

The device 168 includes a fulcrum 172, which is affixed to the hyoidbone 170 by a bone screw 174. Extending from the fulcrum 172 is anactuator 176 having a generally horizontal first arm 178 and a generallyvertical second arm 180.

Suitable material for arms 178 and 180 are an inert rigid material suchas titanium, shaped memory alloy (Nitinol®), or a biologicallycompatible polymer such as reinforced polytetraf luoroethylene(Teflon®). Suitable materials, configuration, and length of arms 178 and180 can be varied to maximize comfort and to minimize interference withswallowing and speech.

The primary magnet 36 is affixed to one end of the first arm 178.

A collar 158 carries the secondary magnet 38. The patient wears a collar158 when asleep. The collar 158 is similar to the collar previouslydescribed and shown in FIGS. 28 and 29. However, as FIG. 30 shows, inthis arrangement, the distance D2 between the primary magnet 36 and thesecondary magnet 38 is considerably less than the distance D1 betweenthe primary magnet 36 and the secondary magnet 38 shown in FIG. 28. Asshown in FIG. 30, the collar 158 orientates the secondary magnet 38 suchthat the primary direction of magnetic flux (represented by an arrow inFIG. 30) attracts the primary magnet 36 in a downward direction.

The collar magnet 38 is encased in a soft casing material 160,preferably polymer foam, and affixed to a bracket 162, e.g., by adhesiveor fastener 164, which is further affixed, e.g., by adhesive or fastener166, to the collar 158 as was described for the earlier embodiment.

The material is configured to contact the chin 165 at 182, preventingthe collar 158 from moving upward due to the magnetic pull or due tomovement during sleep, assuring that comfort and proper position aremaintained. A space 184 between the bottom of the chin 165 and the topof the secondary magnet 38 provides room for the tissue and musclebetween the mandible 186 and the hyoid bone 170 to be pulled downwardlyby the attraction between the secondary magnet 38 and the primary magnet36.

As the primary magnet 36 is pulled downward, the tissue between themandible 186 and hyoid bone 170 flexes downward, exerting a rotationalforce on the actuator arms 178 and 180, with the center of rotationbeing the fulcrum 172. At the upper end of the second arm 180 there is apaddle 188 configured to press in an anterior direction on the musculartissue within the tongue 34. This action holds the tongue 34 in ananterior direction, preventing occlusion of the airway by the back ofthe tongue 34.

In alternate embodiment (see FIG. 31), the actuator arms 178 and 180extend from a U-shaped stirrup 190 providing a fulcrum point 192. Theactuator 176 is positioned in front of and above the hyoid bone 170 andsutured in place to the soft tissue, leaving approximately 2 to 3 mm oftissue between the stirrup 190 and the hyoid bone 170. The actuator 176is desirably coated with an expanded Teflon® PTFE(polytetrafluoroethylene) to encourage in growth of the tissue as thesutures 194 dissolve.

B. Mandible Attachment

1. FIRST EMBODIMENT

FIG. 32 shows another system for treating sleep-related breathingdisorders such as snoring, upper airway resistance syndrome andobstructive sleep apnea. The system includes a device 196 carrying amore mobile primary magnet 36, which is implanted within the tongue 34,and a less mobile secondary magnet 38, which is carried by an externalcollar 158 against the chin.

The device 196 comprises a bracket 198 coupled to an arm 200. In thisembodiment, the bracket 198 is affixed to the posterior portion of themandible 186 using a bone screw 174 or other permanent means ofattachment. The mandible 186 provides a stable platform.

The arm 200 is implanted into tongue tissue, reaching toward the back ofthe tongue 34 and sweeping upward. At the upper end of the arm 200 thereis a paddle 201 configured to press in an anterior direction on themuscular tissue within the tongue 34.

The arm 200 is pivotally attached to the bracket 198 with the pivot orhinge 202 allowing rotational movement around a point near the upperrear edge of bracket 198. The primary magnet 36 is permanently affixedto the lower surface of the arm 200 approximately one-half of the waybetween the two ends of the arm 200.

A secondary magnet 38 is carried by an external collar 158, to be wornagainst the chin during sleep, as previously described. The secondarymagnet 38 may be encased in a soft (preferably polymeric foam) pad 160to provide comfort for the wearer, as previously described (see e.g.,FIGS. 28 and 29). The foam pad 160 is affixed to and supported by abracket 162 that is further affixed to a collar 158, as also previouslydescribed. However, in this arrangement, the mounting position of themagnets 36 and 38 are in a more posterior direction than that of theembodiment shown in FIGS. 30 and 31, to effectuate desired movement ofthe tongue 34.

In this arrangement, the polarities of the primary and secondary magnets36 and 38 are non-complementary, i.e., the magnets 36 and 38 have likepolarity. The like polarities establish repelling magnetic forces.

Thus, as depicted by arrow 204 in FIG. 32, due to the like polarities,the more mobile primary magnet 36 is repelled away from less mobilesecondary magnet 38. This repulsive force imparts a lifting moment tothe device 196, preventing the tongue 34 from falling backward into themouth and thereby avoiding an apneic or hypopneic event. In thisarrangement, the direction of lift is upward and forward, as depicted byarrow 206 in FIG. 32, because the pivot point of arm 200 causes the pathof travel to describe a radius centered on the upper rear corner of thebracket 198.

With reference now to FIG. 33, an alternative embodiment of the device196 is illustrated. A bracket 198 is firmly affixed to the posteriorsurface of the mandible 186 using a bone screw 174. A bellcrank 208 isrotatably mounted to bracket 198, pivoting about a center point 210. Aprimary magnet 36 is affixed to the lower surface of the bellcrank 208and positioned at the anterior end of the bellcrank 208.

For sleep, the user wears a collar apparatus 158 carrying a secondarymagnet 38, as described earlier (see e.g., FIGS. 28 and 29). In thisarrangement, the polarities of the primary and secondary magnets 36 and38 are complentary, i.e., the polarities are not alike. Thus, the lessmobile secondary magnet 38 will attract the more mobile primary magnet36. The attraction imparts a downward pull, as depicted by arrow 212 inFIG. 33, on the anterior portion of the bellcrank 208. A downward forceon the arm 200 at will translate to an arcuate force, represented byarrow 214 in FIG. 33, resisting the tendency of the tongue 34 to fallbackward during sleep and attendant muscle relaxation.

The materials of construction of the device 168 or 196 are desirably ofbiologically inert materials that have demonstrated the ability to beimplanted and remain within the body without causing irritation,inflammation or rejection by the body. Suitable materials are polymeric(plastic) materials or metallic materials such as titanium or shapedmemory alloys. The moving or floating parts of the present invention arepreferably made of materials that are somewhat flexible and that willnot affect speech or swallowing during non-sleeping hours. The implantedportions of the device 168 or 196 may be of, or coated by, a materialthat promotes in growth or attachment of the tissue to the implanteddevice 168 or 196. Such materials are well known to the medical deviceindustry.

It is believed that the restraint of the tongue 34 for treatingsleep-related breathing disorders such as snoring, upper airwayresistance syndrome and obstructive sleep apnea, does not require largeforces. It is estimated that the required forces to be imparted to thedevice 168 or 196 when the collar 158 is worn are in the range of about15 to 60 grams.

Thus, the lifting/rotating arms 178, 180 and 200 in the embodimentsrepresented by FIGS. 30 to 33 could be composed of a metallic coilspring that is imbedded in a polymeric coating, such as PTFE (Teflon®),or a silicone rubber compound. The degree of flexibility and rigidityrequired to provide sufficient lifting force during sleep, while notinterfering with normal daytime activities such as speech andswallowing, could be readily attained by varying the wire gage, numberof turns and the type of covering material.

2. SECOND EMBODIMENT

FIGS. 34 to 37 illustrate another embodiment of the invention in which adevice 216 carrying a primary magnet 36 can be implanted within themandible 186 for treating sleep-related breathing disorders such assnoring, upper airway resistance syndrome and obstructive sleep apnea.The device 216 comprises a capsule 218 coupled to a lifting arm 220. Thecapsule 218 includes a bore 222 in which the primary magnet 36 ispositioned slidably and stabilized against the top end of the bore 222by a light force coil spring 224. Below the magnet 36 is a linkagemechanism 226 on which the magnet 36 rests or, alternatively, isattached to.

The linkage mechanism 226 has a connecting rod 230 contacting the bottomsurface of the magnet 36, which is coupled to a bellcrank 232, whichpivots about a pivot point 228. The bellcrank 232 is coupled to thelifting arm 220 by a pull wire 236.

It is to be understood that the length of the arms of the bellcrank 232on opposite sides of the pivot point 228 may dissimilar. For instance,the bellcrank arm above the pivot point 228 may be longer than thebellcrank arm below the pivot point 228 to gain a leverage advantage. Inthis arrangement, travel distance for the magnet 36 is traded forincreased force at the end of the lower arm 232. These lengths may bedesigned to deliver the desired force at the end of the bellcrank 232connected to the pull wire 236.

The proximal end of a pull wire 236 is attached to the bellcrank 232,e.g., threaded through hole 238 and tied. The wire 236 extends through abore 240 in the lifting arm 220, the distal end of the wire 236 beinganchored to the interior of the distal end of the lifting arm 220, e.g.,threaded through hole 242 and tied. The lifting arm 220 includes asegmented portion .244, such that as the pull wire 236 is drawn back,the segmented portion 244 of the lifting arm 220 curves, as representedby arrow in FIG. 35. The arm 220 includes a paddle 246 at the posteriorend that is configured to press in an anterior direction on the musculartissue within the tongue 34 as the arm 220 curves.

The method of curving a hollow tube is well known in the medical deviceindustry and is used for many types of steerable therapeutic anddiagnostic devices, such as catheters and endoscopes. The exterior ofthe curvable lifting arm 220 is desirably coated with a material such asexpanded PTFE to promote in growth of tissue and provide stability forthe implanted lifting arm 220.

To implant the device 216, the surgeon performs a procedure to open theskin and tissue beneath the chin 165 to gain access to the lower surfaceof the mandible 186. The surgeon then drills a hole in the mandible 186of an appropriate diameter and depth for the capsule 218 to beimplanted.

The capsule 218 is then anchored into the mandible 186 using a bonecement of the type used in joint implants and similar procedures. Next,using a special procedure needle, the surgeon uses a locating templatethat temporarily attaches to the bottom of the capsule 218 to guide theprocedure needle to create a path for the lifting arm 220. The surgeonthen inserts the special needle, palpating the tongue 34 to determinethe optimal location for the posterior of the lifting arm 220. Theneedle is then withdrawn and the sterile lifting arm 220 is slid intothe incision made by the special needle. The anterior end of the liftingarm 220 includes an attachment means that will allow the lifting arm 220end to be sealed to the bottom of the magnet capsule 218. The incisionis then closed.

After a suitable healing time to allow swelling and soreness to subside,the patient may begin to wear a collar 158 carrying the secondary magnet38, similar to that shown in FIGS. 28 and 29. As best seen in FIG. 36,in the absence of magnetic forces acting on the primary magnet 36 (i.e.,when the collar 158 is not being worn) the primary magnet 36 restsagainst the top end of the bore 222, as previously noted. When thecollar 158 is worn, attractive magnetic forces between the complementarymagnets 36 and 38 draw more the mobile primary magnet 36 to the bottomof the capsule 218, as shown in FIG. 37. The downward movement of magnet36 results in the lower arm 232 pivoting in an upward direction to drawthe pull wire 236 back (anterior).

As the wire 236 is drawn back, the segmented portion 244 of the liftingarm 220 curves upward to effectuate an upward and anterior movement ofthe tongue 34, mediating against OSA and hypopneas. Because the tongue34 will not tend to occlude the airway, snoring that is exacerbated by arearward tongue 34 position may also by reduced.

VI. Another System Overview (Tissue Displacement Using Suction)

FIGS. 38 to 41 illustrate another system 300 for treating sleep-relatedbreathing disorders such as snoring, upper airway resistance syndromeand obstructive sleep apnea. Unlike the systems previously discussed,the system 300 does not employ magnets or ferrous materials. Instead,the system 300 uses suction (i.e., a vacuum) to position, stabilize andmaintain a preferred orientation of tissue in an oral cavity and airwayin both humans and animals. By using suction to move and stabilizetissue in a desired location and shape, the system 300 mediates orprevents the obstruction of the upper airway that results insleep-related breathing disorders. And, as will be described, the system300 achieves these results without permanent modification of theanatomy.

As shown in FIG. 38, the system 300 includes an oral device 302, whichconforms to the teeth or hard palate (see FIG. 41). The oral device 302has the structural features of oral device 104 shown in FIG. 18, whichhave been previously described and share common reference numerals. Likethe oral device 104, the oral device 302 is held in place by an intimatefit to the teeth and/or hard palate 28 (as shown in FIG. 41) and/or bysprings or elastic bands, all of which are well known and common indental appliances. Like the oral device 104, the oral device 302 isintended to be worn by the individual during sleep and then removedduring waking hours.

As shown in FIG. 38, the system 300 also includes a suction cup 304, ahollow supporting stem 306, and a vacuum bulb 308, which are carried bythe oral device 302.

As FIGS. 38 and 39 show, the suction cup 304 desirably has a bead 310which surrounds the face of the suction cup 304. The bead 310 is sizedand configured to press against the surface of the tissue (see FIG.40B), creating an area of increased contact pressure, resulting in atight seal against the tissue. Perforations 312 in the face of thesuction cup 304 reach into the plenum chamber 324 within the suction cup304 (see FIG. 39). The face of the suction cup 304 which contacts thetissue may also have a shallow waffle type grid pattern to enhanceevacuation of air from the area between the suction cup 304 and thesurface of the tissue.

The stem 306 supports the suction cup 304. The stem 306 is hollow totransport air between the suction cup 304 and the vacuum bulb 308. Thestem 306 is desirably flexible so that movement of the soft palate anduvula is not impaired, while imparting sufficient force to pull the softpalate and uvula in an anterior direction.

As FIG. 39 shows, the vacuum bulb 308 communicates with a check valve314 and an exhaust valve 316. The body of the vacuum bulb 308 may be aflexible material with sufficient memory to expand after beingdepressed, creating suction forces, which are communicated via thehollow stem 306 to the suction cup 304.

The bulb 308, the stem 306, and the suction cup 304 may be slidablymounted onto the oral device 302, in the manner that magnets wereslidably affixed to the oral device 104 described earlier. In use (seeFIG. 40A), the individual would slide the vacuum bulb 308 in a backward(posterior) direction in the mouth, causing the suction cup 304 to comeinto contact with the soft palate 30 and/or uvula 32. As FIG. 40A shows,the individual would then depress the vacuum bulb 308 by pressing upward(shown by an arrow in FIG. 40A). Air within the bulb 308 will exitthrough the exhaust valve 316 (shown by arrows in FIG. 40A), since airis unable to move toward the suction cup 304 because the check valve 314prevents air movement in that direction.

As FIG. 40B shows, when the pressure against the vacuum bulb 308 isreleased (shown by an arrow in FIG. 40B), the bulb 308 expands, reducingthe internal pressure. This creates a suction in the suction cup 304,because the check valve 314 permits air movement toward the vacuum bulb308 (as shown by an arrow in FIG. 40B). If desired, the individual maypump the suction cup 304 itself to further exhaust air, if needed, toassure an adequate suction grip on the tissue.

The exhaust valve 316 may be of a pressure limiting type of valve thatwill open if a predetermined amount of suction has been exceeded. Such avalve could have a calibrated spring to prevent maintaining an amount ofsuction that might result in tissue damage. If the vacuum bulb 308 wasdepressed more than required, the pressure regulating exhaust valvewould leak until the predetermined level of suction was reached and thenseal against further leakage.

The vacuum bulb 308 may be placed on the occlusal surfaces between upperand lower molars, allowing the suction to be created and replenished bya biting action. Alternatively, a primary suction bulb may be arrangedas shown in FIGS. 38 and 39, and the amount of suction needed toovercome leakage may be supplied by a smaller occlusal bulb.

Various ancillary means may be applied to prevent leakage of the suctionduring the sleep period. For instance, a sealing gel material or dentaladhesive might be applied to the bead of the suction cup, preventing airleakage during the night, in which case the suction applied when thedevice is placed in the mouth would be sufficient for the entire sleepperiod.

FIGS. 42 and 43 illustrate an alternative system 400 for treatingsleep-related breathing disorders such as snoring, upper airwayresistance syndrome and obstructive sleep apnea. The system 400, likethe system 300 uses suction (i.e., a vacuum) to position, stabilize andmaintain a preferred orientation of tissue in an oral cavity and airwayin both humans and animals. More particularly, the system 400 appliessuction to stabilize and maintain the tongue 34 in a preferredorientation in the oral cavity and airway. The benefits of maintainingthe tongue 34 in a preferred orientation using primary and secondarymagnets have been previously described, and the use of suction achievescomparable benefits.

As shown in FIG. 42, the system 400 includes an oral device 402, whichcan be sized and configured to be carried by either the bottom or upperteeth. In FIG. 42, the oral device 402 is sized and configured to becarried by the bottom teeth and has the structural features of oraldevice 126 shown in FIG. 22, which have been previously described and,accordingly, share common reference numerals. Like the oral device 126,the oral device 402 is held in place by an intimate fit to the bottomteeth. Like the oral device 126, the oral device 402 is intended to beworn by the individual during sleep and then removed during wakinghours.

As also shown in FIG. 42, the system 400 also includes a left and rightpair of suction cups 304 carried by the oral device 402. Each suctioncup 304 has a hollow supporting stem 306 and a vacuum bulb 308, whichare also carried by the oral device 402. These elements are comparablein structure and function to the elements 304, 306, and 308 shown anddescribed in the embodiment illustrated in FIGS. 38 and 39 and are,accordingly, assigned the same reference numeral.

As in the embodiment shown in FIGS. 38 and 39, the suction cups 304 inFIG. 42 desirably each has a bead 310 that is sized and configured topress against the adjacent tissue, which, in this instance, is a sidesurface of the tongue 34 (see FIG. 43). As in the FIG. 39 embodiment,the vacuum bulb 308 in FIG. 42 communicates with a check valve 314 andan exhaust valve 316, to create suction in the respective suction cup304 in response to an individual squeezing the vacuum bulb 308.

In use (see FIG. 43), the individual installs the oral device 402 on thebottom teeth. This installation brings the left and right suction cups304 into association with the adjacent left and right sides of thetongue 34. The individual then depresses the vacuum bulbs 308 bypressing against them, either individually or simultaneously. When thepressure against the respective vacuum bulb 308 is released, the bulb308 expands to create a suction in the associated suction cup 304. Thishas been previously described with reference to FIGS. 40A and 40B. InFIG. 43, the suction causes the suction cups 34 to grip the sides of thetongue 34.

The suction cups 304 are maintained by the oral device 402 in a desiredanterior position within the oral cavity. Held relatively immobile bythe bottom teeth, the suction cups 304 exert an anterior pulling forceto the tongue 34. The pulling force draws the tongue toward a moreforward, stabilized position, shown in solid lines in FIG. 43. Theanterior position of the tongue 34 shown in FIG. 43 is comparable to theanterior position affected by the magnets 36′/38′ shown in FIG. 23. Thestabilization of the tongue 34 in an anterior direction prevents apotential obstruction of the airway (which is shown in phantom lines inFIG. 43).

As before described, one or more smaller, secondary vacuum bulbs 410 canbe located on the oral device 402 in the occlusal area between upper andlower molars (see FIG. 42). The vacuum bulbs 410 are coupled to thesuction cups 304 and apply suction to the cups 304 by biting action. Inthis arrangement, primary suction can be supplied by the main vacuumbulbs 308, and maintenance suction can be applied by biting on thesecondary vacuum bulbs 410.

Alternatively, one or more suction cups 304 for gripping the sides ofthe tongue, along with the associated stems 306 and vacuum bulbs 308,can be carried by an oral device carried by the upper teeth, in a mannercomparable to the way the magnets 132 are carried by the oral device 152in FIG. 27.

The above described embodiments of this invention are merely descriptiveof its principles and are not to be limited. The scope of this inventioninstead shall be determined from the scope of the following claims,including their equivalents.

1. An implant assembly comprising a first implant element sized andconfigured for implantation in a bone region within an oral cavity, asecond implant element sized and configured for implantation in a tongueregion within the oral cavity, and a third implant element coupled tothe first and second implant elements within the oral cavity, the thirdimplant element being capable of applying force between the first andsecond implant elements such that the implant, in use, resists posteriormovement of the tongue within the oral cavity.
 2. An implant assemblyaccording to claim 1 wherein the first implant element is sized andconfigured for implantation in a mandible.
 3. An implant assemblyaccording to claim 1 wherein the first implant element is sized andconfigured for implantation in a hyoid bone.
 4. An implant assemblyaccording to claim 1 wherein the third implant element includes acomponent that applies force between the first and second implantelements in response to magnetic interaction with another component. 5.An implant assembly according to claim 1 wherein the second implantelement pivots relative to the first implant element in response to theforce applied by the third implant element.
 6. An implant assemblyaccording to claim 1 wherein the third implant element includes anelongated member that applies the force.
 7. An implant assemblyaccording to claim 1 wherein the third implant element includes anelongated member that pulls the second implant element toward the firstimplant element.
 8. An implant assembly according to claim 1 wherein thethird implant element includes an elongated member that applies tensionbetween the first and second implant elements.
 9. An implant assemblycomprising a first implant element sized and configured for implantationin a bone region within an oral cavity, a second implant element sizedand configured for implantation in a tongue region within the oralcavity, and a third implant element coupled to the first and secondimplant elements within the oral cavity, the third implant element beingcapable of applying tension between the first and second implantelements such that the implant, in use, resists posterior movement ofthe tongue within the oral cavity.
 10. An implant assembly according toclaim 9 wherein the first implant element is sized and configured forimplantation in a mandible.
 11. An implant assembly according to claim 9wherein the third implant element includes a component that appliestension between the first and second implant elements in response tomagnetic interaction with another component.
 12. An implant assemblyaccording to claim 9 wherein the third implant element includes anelongated member.
 13. A method comprising implanting a first implantelement in a bone region within an oral cavity, implanting a secondimplant element in a tongue region within the oral cavity, and resistingposterior movement of the tongue within the oral cavity by coupling thefirst implant element to the second implant element within the oralcavity.
 14. A method according to claim 13 wherein the first implantelement is implanted in a mandible.
 15. A method according to claim 13wherein the first implant element is implanted in a hyoid bone.
 16. Amethod according to claim 13 wherein resisting posterior movement of thetongue within the oral cavity includes a generation of a magnetic fieldaffecting the first and second implant elements.
 17. A method comprisingimplanting a first implant element in a bone region within an oralcavity, implanting a second implant element in a tongue region withinthe oral cavity, and resisting posterior movement of the tongue withinthe oral cavity by placing into tension a third implant element betweenthe second implant element and the first implant element within the oralcavity.
 18. A method according to claim 17 wherein the first implantelement is implanted in a mandible.
 19. A method according to claim 17wherein the third element comprises an elongated member placed intotension between the first and second implant elements.
 20. A methodaccording to claim 17 wherein by placing into tension a third implantelement between the second implant element and the first implant elementincludes a generation of a magnetic field.